CYB003: Deuterated Psilocybin Analog with FDA Breakthrough Therapy Designation

CYB003 is a proprietary deuterated molecule related to psilocybin, which is part of a family of molecules called indolamines that includes more common neurotransmitters like serotonin. CYB003 is a new chemical entity (NCE) and has been granted FDA Breakthrough Therapy Designation for the adjunctive treatment of Major Depressive Disorder (MDD).

Development Status: Completed Phase 2 trial of CYB003 in participants with moderate to severe MDD

Next Steps: Initiate Phase 3 pivotal, multinational trial of CYB003 in MDD summer 2024

CYB003 received the first known Breakthrough Therapy Designation for an adjunctive psychedelic-based therapy for MDD

This designation acknowledges the significant unmet medical need for more effective treatment of MDD. It also provides validation that Phase 2 data for CYB003 shows preliminary evidence for significant clinical improvements over existing therapies.

Breakthrough Therapy Designation expedites the development pathway for CYB003

Breakthrough Therapy Designation benefits:

  • All Fast Track Designation features, including Rolling Review for NDA

  • More intensive FDA guidance and discussion, including planned clinical trials and plans for expediting manufacturing development strategy

  • CYB003 is eligible for Priority Review and Accelerated Approval

Clinical Validation for CYB003 in MDD: Robust and Sustained Remission Rates up to Four Months

To date, Cybin has announced positive Phase 2 topline results for CYB003 in participants with moderate to severe MDD, evaluating the efficacy and safety of CYB003 with two doses, at up to 4 months.

Rapid onset of effect

Improvement in symptoms after single dose

Large improvement in symptoms

At 3 weeks:

12mg better than placebo on MADRS by 14.1 points (p=0.0001), Cohen’s d=2.31

16mg better than placebo on MADRS by 13 points (p=0.008), Cohen’s d=2.31

Incremental benefit of second dose

Average 5.8 points improvement on the MADRS after 2nd dose (12mg) 

>75% response rates and up to 80% remissions rates (12mg) after a 2nd dose

Durable efficacy

Benefit sustained 4 months after 2nd dose with 60% of patients on 12mg and 75% of patients on 16mg in remission

Favorable safety profile

Excellent safety and tolerability profile – all reported AEs mild to moderate; no AEs of suicidality

Clear path to NDA

Phase 3 plan aligned with FDA at end of phase 2 meeting

Strong and Durable Effects 4 Months After 2 Doses of CYB003

Mean 22-point reduction in MADRS scores from baseline at 4 months after just two doses of CYB003

Sustained benefit 4 months after 2nd dose with 60% of patients on 12 mg and 75% on 16 mg in remission

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